Under construction – not a live service
Sign in
Taking people in NetherlandsNo phase

Tests a temporary heart pump during high-risk coronary artery procedures

Tests a temporary heart pump in adults having complex, higher-risk artery-opening procedures.

Key facts

Who runs it
Amsterdam UMC, location VUmc
Where
Amsterdam, Geleen, Groningen, Leiden, Maastricht, Nijmegen, The Hague, and Utrecht, NetherlandsSee the 8 sites
Trial code
Registry title
Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
Status
Recruiting
People taking part
98 people, planned
Started
25 Jan 2024
Expected to end
1 Mar 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Mechanical circulatory support with the Pulsecath iVAC2L device
Record updated
2 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a weak heart who need a complex, higher-risk procedure to open blocked heart arteries. It tests a temporary mechanical heart pump, the Pulsecath iVAC2L, during the procedure.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Weak heart pumping (LVEF <30%, or <35% with moderate MR, or <40% with severe MR) and complex left main artery disease or an equivalent, or the last remaining native vessel. Blood circulation must be stable (SCAI A-B).
Earlier treatment
The heart team must agree that a high-risk PCI, with or without mechanical circulatory support (MCS), is needed. Stroke or a major bleeding event in the last 3 months is not allowed.

Main reasons for not taking part

  • Severe aortic regurgitation or severe aortic valve stenosis, a mechanical aortic valve, or a known blood clot in the left ventricle
  • Cardiogenic shock (SCAI CSWG stage C-E) or being on a breathing machine
  • Artery disease in the legs that would prevent placing the pump
  • Bleeding disorder, recent bleeding, or refusing blood transfusions
  • Pregnancy, BMI above 35, or kidney replacement therapy

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age ≥18 years AND
  • Multidisciplinary heart team consensus for high risk PCI +/- MCS AND
  • Hemodynamically stable (SCAI A-B) AND
  • LVEF <30% OR LVEF <35% with moderate MR OR LVEF <40% with severe MR AND
  • Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native)

Who cannot take part

  • Contraindications for Pulsecath IVAC2L:; severe aortic regurgitation; known presence of an LV thrombus (contrast echo/MRI); Mechanical aorta valve prosthesis; severe aortic valve stenosis; peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device
  • Stroke <3 months
  • Major bleeding event <3 months
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy
  • Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
  • Cardiogenic shock defined as either SCAI CSWG stage C-E
  • Patient is intubated and mechanically ventilated
  • Pregnancy, or suspected thereof
  • BMI > 35
  • Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures

Where in Netherlands

  • Amsterdam University Medical CenterAmsterdam, NetherlandsContact: Tijmen H. Ris, MDTaking people
  • ZuyderlandGeleen, NetherlandsContact: Alexander J.J. Ijsselmuiden, MD, PhDTaking people
  • University Medical Center GroningenGroningen, NetherlandsContact: Eric, MD, PhDTaking people
  • Leiden University Medical CenterLeiden, NetherlandsContact: Jose M Montero-Cabezas, MD, PhDTaking people
  • Maastricht University Medical CenterMaastricht, NetherlandsContact: Pieter A. Vriesendorp, MD, PhDTaking people
  • Radboud University Medical CenterNijmegen, NetherlandsContact: Robert-Jan van Geuns, MD, PhDTaking people
  • Haaglanden Medical CenterThe Hague, NetherlandsContact: Bas van der Hoeven, MDTaking people
  • University Medical Center UtrechtUtrecht, NetherlandsContact: Adriaan kraaijeveld, MD, PhDTaking people

About the trial

What the trial wants to find out

If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual.

Read full original descriptionShow less

During the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs.

To help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it.

This study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.

The 2 groups in the trial

  • Standard-of-Care (without MCS)No study treatment, for comparison

    Patients will undergo high-risk PCI without upfront use of MCS

  • Pulsecath iVAC2L (with MCS)Treatment being tested

    Patients will undergo high-risk PCI with upfront use of the Pulsecath iVAC2L (MCS)

    Treatment: Mechanical circulatory support with the Pulsecath iVAC2L device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures
Plain-language title
Tests a temporary heart pump during high-risk coronary artery proceduresGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 February 2026